General Chapters - 1160 - Pharmaceutical Calculations in Prescription Compounding

11/10/2016
GeneralChapters:<1160>PHARMACEUTICALCALCULATIONSINPRESCRIPTIONCOMPOUNDING
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PHARMACEUTICALCALCULATIONSINPRESCRIPTIONCOMPOUNDING
INTRODUCTION
Thepurposeofthischapteristoprovidegeneralinformationtoguideandassistpharmacistsinperformingthenecessary
calculationswhenpreparingorcompoundinganypharmaceuticalarticle(seePharmaceuticalCompoundingNonsterile
Preparations 795 ,PharmaceuticalCompoundingSterilePreparations 797 ,andGoodCompoundingPractices
1075 )orwhensimplydispensingprescriptions(seeStabilityConsiderationsinDispensingPractice 1191 ).
Correctpharmaceuticalcalculationscanbeaccomplishedbyusing,forexample,properconversionsfromone
measurementsystemtoanotherandproperlyplaceddecimalpoints,byunderstandingthearithmeticalconcepts,andby
payingcloseattentiontothedetailsofthecalculations.Beforeproceedingwithanycalculation,pharmacistsshoulddothe
following:(a)readtheentireformulaorprescriptioncarefully(b)determinewhichmaterialsareneededandthen(c)select
theappropriatemethodsofpreparationandtheappropriatecalculation.
Thereareoftenseveralwaystosolveagivenproblem.Logicalmethodsthatrequireasfewstepsaspossibleshouldbe
selectedinordertoensurethatcalculationsaredonecorrectly.Thebestapproachistheonethatyieldsresultsthatare
accurateandfreeoferror.Thepharmacistmustdoublecheckeachcalculationbeforeproceedingwiththepreparationofthe
articleorprescriptionorder.Onewayofdoublecheckingisbyestimation.Thisinvolvesroundingoffthequantitiesinvolved
inthecalculation,andcomparingtheestimatedresultwiththecalculatedvalue.
Finally,thefollowingstepsshouldbetaken:thedosageofeachactiveingredientintheprescriptionshouldbecheckedall
calculationsshouldbedoublychecked,preferablybyanotherpharmacistandwhereinstrumentsareusedincompounding,
theyshouldbecarefullycheckedtoascertainthattheywillfunctionproperly.SeeUSPgeneralchaptersAerosols,Nasal
Sprays,MeteredDoseInhalers,andDryPowderInhalers 601 ,DeliverableVolume 698 ,DensityofSolids 699 ,
OsmolalityandOsmolarity 785 ,pH 791 ,PharmaceuticalCompoundingNonsterilePreparations 795 ,
PharmaceuticalCompoundingSterilePreparations 797 ,Viscosity 911 ,SpecificGravity 841 ,CleaningGlass
Apparatus 1051 ,MedicineDropper 1101 ,PrescriptionBalancesandVolumetricApparatus 1176 ,Teaspoon
1221 ,WeighingonanAnalyticalBalance 1251 ,andGoodCompoundingPractices 1075 forinformationon
specificinstruments.
BASICMATHEMATICALCONCEPTS
SIGNIFICANTFIGURES
http://www.pharmacopeia.cn/v29240/usp29nf24s0_c1160.html
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Expressedvaluesareconsideredsignificanttothelastdigitshown(seeSignificantFiguresandTolerancesintheGeneral
Notices).Significantfiguresaredigitswithpracticalmeaning.Theaccuracyofthedeterminationisimpliedbythenumberof
figuresusedinitsexpression.Insomecalculationszerosmaynotbesignificant.Forexample,forameasuredweightof
0.0298g,thezerosarenotsignificanttheyareusedmerelytolocatethedecimalpoint.Intheexample,2980g,thezero
mayalsobeusedtoindicatethedecimalpoint,inwhichcasethezeroisnotsignificant.Alternately,however,thezeromay
indicatethattheweightiscloserto2981gor2979g,inwhichcasethezeroissignificant.Insuchacase,knowledgeof
themethodofmeasurementwouldberequiredinordertoindicatewhetherthezeroisorisnotsignificant.Inthecaseofa
volumemeasurementof298mL,allofthedigitsaresignificant.Inagivenresult,thelastsignificantfigurewrittenis
approximatebutallprecedingfiguresareaccurate.Forexample,avolumeof29.8mLimpliesthat8isapproximate.The
truevolumefallsbetween29.75and29.85.Thus,29.8mLisaccuratetothenearest0.1mL,whichmeansthatthe
measurementhasbeenmadewithin0.05mL.Likewise,avalueof298mLisaccuratetothenearest1mLandimpliesa
measurementfallingbetween297.5and298.5,whichmeansthatthemeasurementhasbeenmadewithin0.5mLandis
subjecttoamaximumerrorcalculatedasfollows:
Azeroinaquantitysuchas298.0mLisasignificantfigureandimpliesthatthemeasurementhasbeenmadewithinthe
limitsof297.95and298.05withapossibleerrorcalculatedasfollows:
EXAMPLES
1.29.8mL=29.80.05mL(accuratetothenearest0.1mL)
Thedegreeofaccuracyinthelastexampleisgreatest.Thus,thenumberofsignificantfiguresprovidesanestimatebothof
truevalueandofaccuracy.
EXAMPLESOFSIGNIFICANTFIGURES
NumberofSignificant
Measurement
Figures
2.98
2.980
3
4
0.0298
0.0029
3
2
CalculationsAllfiguresshouldberetaineduntilthecalculationshavebeencompleted.Onlytheappropriatenumberof
significantfigures,however,shouldberetainedinthefinalresult.
Determiningthenumberofsignificantfigures
SumsandDifferencesWhenaddingorsubtracting,thenumberofdecimalplacesintheresultshallbethesameasthe
numberofdecimalplacesinthecomponentwiththefewestdecimalplaces.
EXAMPLE
11.5+11.65+9.90=33.1
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ProductsandQuotientsWhenmultiplyingordividing,theresultshallhavenomoresignificantfiguresthanthe
measurementwiththesmallestnumberofsignificantfiguresenteringintothecalculation.
EXAMPLE
4.26621=90
RoundingOffForrulesonroundingoffmeasurementsorcalculatedresults,seeInterpretationofRequirementsunder
SignificantFiguresandTolerancesintheGeneralNotices.Note,however,thatintheexampleabove,if21isanabsolute
number(e.g.,thenumberofdoses),thentheanswer,89.586,isroundedoffto89.59whichhas4significantfigures.
LOGARITHMS
Thelogarithmofanumberistheexponentorthepowertowhichagivenbasemustberaisedinordertoequalthatnumber.
Definitions
pH=log[H+],and
pKa=logKa
pH=log[H+],andpKa=logKa,where[H+]isthehydrogenionconcentrationinanaqueoussolutionandKaisthe
ionizationconstantoftheacidinanaqueoussolution.The[H+]=theantilogarithmof(pH),andtheKa=theantilogarithm
of(pKa).
ThepHofanaqueoussolutioncontainingaweakacidmaybecalculatedusingtheHendersonHasselbalchequation:
pH=pKa+log[salt]/[acid]
EXAMPLE
Asolutioncontains0.020molesperLofsodiumacetateand0.010moleperLofaceticacid,whichhasapKavalueof
4.76.CalculatethepHandthe[H+]ofthesolution.Substitutingintotheaboveequation,pH=4.76+log(0.020/0.010)=
5.06,andthe[H+]=antilogarithmof(5.06)=8.69106.
BASICPHARMACEUTICALCALCULATIONS
Theremainderofthischapterwillfocusonbasicpharmaceuticalcalculations.Itisimportanttorecognizetherulesinvolved
whenadding,subtracting,dividing,andmultiplyingvalues.Theinterrelationshipsbetweenvariousunitswithinthedifferent
weighingandmeasuringsystemsarealsoimportantandhavetobeunderstood.
CALCULATIONSINCOMPOUNDING
Thepharmacistmustbeabletocalculatetheamountorconcentrationofdrugsubstancesineachunitordosageportionof
acompoundedpreparationatthetimeitisdispensed.Pharmacistsmustperformcalculationsandmeasurementstoobtain,
theoretically,100%oftheamountofeachingredientincompoundedformulations.Calculationsmustaccountfortheactive
ingredient,oractivemoiety,andwatercontentofdrugsubstances,whichincludesthatinthechemicalformulasof
hydrates.OfficialdrugsubstancesandaddedsubstancesmustmeettherequirementsunderLossonDrying 731 ,
whichmustbeincludedinthecalculationsofamountsandconcentrationsofingredients.Thepharmacistshouldconsider
theeffectofambienthumidityonthegainorlossofwaterfromdrugsandaddedsubstancesincontainerssubjectedto
intermittentopeningoverprolongedstorage.Eachcontainershouldbeopenedfortheshortestdurationnecessaryandthen
closedtightlyimmediatelyafteruse.
Thenatureofthedrugsubstancethatistobeweighedandusedincompoundingaprescriptionmustbeknownexactly.If
thesubstanceisahydrate,itsanhydrousequivalentweightmayneedtobecalculated.Ontheotherhand,ifthereis
adsorbedmoisturepresentthatiseitherspecifiedonacertificateofanalysisorthatisdeterminedinthepharmacy
immediatelybeforethedrugsubstanceisusedbytheprocedureunderLossonDrying 731 ,thisinformationmustbe
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usedwhencalculatingtheamountofdrugsubstancethatistobeweighedinordertodeterminetheexactamountof
EquationFactor
EquationFactor
EquationFactor
NumericalValue
NumericalValue
NumericalValue
anhydrousdrugsubstancerequired.
Therearecasesinwhichtherequiredamountofadoseisspecifiedintermsofacation[e.g.,Li+,netilmicin(n+)],ananion
[e.g.,F],oramolecule(e.g.,theophyllineinaminophylline).Intheseinstances,thedrugsubstanceweighedisasaltor
complex,aportionofwhichrepresentsthepharmacologicallyactivemoiety.Thus,theexactamountofsuchsubstances
weighedmustbecalculatedonthebasisoftherequiredquantityofthepharmacologicalmoiety.
Thefollowingformulamaybeusedtocalculatetheexacttheoreticalweightofaningredientinacompoundedpreparation:
W=ab/de,
inwhichWistheactualweighedamountaistheprescribedorpharmacistdeterminedweightoftheactiveorfunctional
moietyofdrugoraddedsubstancebisthechemicalformulaweightoftheingredient,includingwatersofhydrationfor
hydrousingredientsdisthefractionofdryweightwhenthepercentbyweightofadsorbedmoisturecontentisknownfrom
thelossondryingprocedure(seeLossonDrying 731 )andeistheformulaweightoftheactiveorfunctionalmoietyof
adrugoraddedsubstancethatisprovidedintheformulaweightoftheweighedingredient.
Example1:TriturateMorphineSulfateUSPandLactoseNFtoobtain10ginwhichthereare30mgofMorphineSulfate
USPforeach200mgofthemorphinelactosemixture.[NOTEClinicaldosagesofmorphinemeanMorphineSulfateUSP,
whichisthepentahydrate.]
EquationFactor NumericalValue
W
weight,ing,ofMorphineSulfateUSP
1.5gofmorphinesulfatepentahydrateintheprescription
b
d
759g/mole
1.0
759g/mole
Example2:AccuratelyweighanamountofAminophyllineUSPtoobtain250mgofanhydroustheophylline.[NOTEThe
powderedaminophyllinedihydrateweighedcontains0.4%w/wadsorbedmoistureasstatedintheCertificateofAnalysis.]
W
weight,inmg,ofAminophyllineUSP(dihydrate)
a
b
250mgoftheophylline
456g/mole
0.996
360g/mole
Example3:AccuratelyweighanamountofLithiumCitrateUSP(containing2.5%moistureasstatedintheCertificateof
Analysis)toobtain200mEqoflithium(Li+).[NOTEOnemEqofLi+isequivalentto0.00694gofLi+.]
W
weight,ing,ofLithiumCitrateUSP(tetrahydrate)
a
200mEqofLi+or1.39gofLi+
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EquationFactor
EquationFactor
NumericalValue
NumericalValue
b
282g/mole
d
0.975
36.94g/moleor20.8g/mole
Example4:AccuratelyweighanamountofNetilmicinSulfateUSP,equivalentto2.5gofnetilmicin.[NOTEUsingthe
procedureunderLossonDrying 731 ,theNetilmicinSulfateUSPthatwasweighedlost12%ofitsweight.]
W
weight,ing,ofNetilmicinSulfateUSP
a
b
2.5g
1442g/mole
0.88
951g/mole
BUFFER SOLUTIONS
DefinitionAbuffersolutionisanaqueoussolutionthatresistsachangeinpHwhensmallquantitiesofacidorbaseare
added,whendilutedwiththesolvent,orwhenthetemperaturechanges.Mostbuffersolutionsaremixturesofaweakacid
andoneofitssaltsormixturesofaweakbaseandoneofitssalts.Waterandsolutionsofaneutralsaltsuchassodium
chloridehaveverylittleabilitytoresistthechangeofpHandarenotcapableofeffectivebufferaction.
Preparation,Use,andStorageofBufferSolutionsBuffersolutionsforpharmacopeialtestsshouldbepreparedusing
freshlyboiledandcooledwater(seeStandardBufferSolutionsunderBufferSolutionsinReagents,Indicators,and
Solutions).TheyshouldbestoredincontainerssuchasTypeIglassbottlesandusedwithinthreemonthsofpreparation.
Buffersusedinphysiologicalsystemsarecarefullychosensoasnottointerferewiththepharmacologicalactivityofthe
medicamentorthenormalfunctionoftheorganism.Commonlyusedbuffersinparenteralproductsforexampleareacetic,
citric,glutamic,andphosphoricacidsandtheirsalts.Buffersolutionsshouldbefreshlyprepared.
TheHendersonHasselbalchequation,notedabove,allowsthepHofabuffersolutionofaweakacidanditssalttobe
calculated.Appropriatelymodified,thisequationmaybeappliedtobuffersolutionscomposedofaweakbaseanditssalt.
BufferCapacityThebuffercapacityofasolutionisthemeasurementoftheabilityofthatsolutiontoresistachangein
pHuponadditionofsmallquantitiesofastrongacidorbase.Anaqueoussolutionhasabuffercapacityof1when1Lof
thebuffersolutionrequires1gramequivalentofstrongacidorbasetochangethepHby1unit.Therefore,thesmallerthe
pHchangeupontheadditionofaspecifiedamountofacidorbase,thegreaterthebuffercapacityofthebuffersolution.
Usually,inanalysis,muchsmallervolumesofbufferareusedinordertodeterminethebuffercapacity.Anapproximate
formulaforcalculatingthebuffercapacityisgramequivalentsofstrongacidorbaseaddedperLofbuffersolutionperunit
ofpHchange,i.e.,(Eq/L)/(pHchange).
EXAMPLE
Theadditionof0.01gequivalentsofsodiumhydroxideto0.25LofabuffersolutionproducedapHchangeof0.50.The
buffercapacityofthebuffersolutioniscalculatedasfollows:
(0.01/0.25)/0.50=0.08(Eq/L)/(pHchange)
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DOSAGECALCULATIONS
SpecialDosageRegimensGeriatricandpediatricpatientsrequirespecialconsiderationwhendesigningdosageregimens.
Ingeriatricpatients,theorgansareoftennotfunctioningefficientlyasaresultofagerelatedpharmacokineticchangesor
disease.Forthesepatients,modificationsindosingregimensareavailableinreferencessuchasUSPDrugInformation.
Forpediatricpatients,whereorgansareoftennotfullydevelopedandfunctioning,carefulconsiderationmustbeapplied
duringdosing.ModificationsindosingregimensforpediatricpatientsarealsoavailableinreferencessuchasUSPDrug
Information.Generalrulesforcalculatingdosesforinfantsandchildrenareavailableinpharmacycalculationtextbooks.
Theserulesarenotdrugspecificandshouldbeusedonlyintheabsenceofmorecompleteinformation.
Theusualmethodforcalculatingadoseforchildrenistousetheinformationprovidedforchildrenforthespecificdrug.The
doseisfrequentlyexpressedasmgofdrugperkgofbodyweightfora24hourperiod,andisthenusuallygivenindivided
portions.
Thecalculationmaybemadeusingthefollowingequation:
(mgofdrugperkgofbodyweight)(kgofbodyweight)=doseforanindividualfora24hourperiod
Alessfrequentlyusedmethodofcalculatingthedoseisbasedonthesurfaceareaoftheindividual'sbody.Thedoseis
expressedasamountofdrugperbodysurfaceareainm2,asshownintheequationbelow:
(amountofdrugperm2ofbodysurfacearea)(bodysurfaceareainm2)=doseforanindividualfora24hourperiod.
Thebodysurfacearea(BSA)maybedeterminedfromnomogramsrelatingheightandweightindosagehandbooks.The
BSAforadultandpediatricpatientsmayalsobedeterminedusingthefollowingequations:
BSA(m2)=squarerootof{[Height(in)Weight(lb)]/3131}
or
BSA(m2)=squarerootof{[Height(cm)Weight(kg)]/3600}.
EXAMPLE
RxforSpironolactoneSuspension25mg/tsp.Sig:9mgBIDforan18montholdchildwhoweighs22lbs.
TheUSPDI2002,22nded.,statesthatthenormalpediatricdosingregimenforSpironolactoneis1to3mgperkgperday.
Inthiscase,theweightofthechildis22lbs,whichequals22lbs/(2.2lbs/kg)=10kg.Thereforethenormaldoseforthis
childis10to30mgperdayandthedoseorderedis18mgperdayasasingledoseordividedinto2to4doses.Thedose
isacceptablebasedonpublisheddosingguidelines.
PERCENTAGECONCENTRATIONS
Percentageconcentrationsofsolutionsareusuallyexpressedinoneofthreecommonforms:
SeealsoPercentageMeasurementsunderConcentrationsintheGeneralNotices.Theabovethreeequationsmaybeused
tocalculateanyoneofthethreevalues(i.e.,weights,volumes,orpercentages)inagivenequationiftheothertwovalues
areknown.
Notethatweightsarealwaysadditive,i.e.,50gplus25g=75g.Volumesoftwodifferentsolventsorvolumesofsolvent
plusasolidsolutearenotstrictlyadditive.Thus50mLofwater+50mLofpurealcoholdonotproduceavolumeof100
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mL.Nevertheless,itisassumedthatinsomepharmaceuticalcalculations,volumesareadditive,asdiscussedbelowunder
ReconstitutionofDrugsUsingVolumesOtherthanThoseontheLabel.
EXAMPLES
1.Calculatethepercentageconcentrations(w/w)oftheconstituentsofthesolutionpreparedbydissolving2.50gof
phenolin10.00gofglycerin.Usingtheweightpercentequationabove,thecalculationisasfollows.
Totalweightofthesolution=10.00g+2.50g=12.50g.
Weightpercentofphenol=(2.50g100%)/12.50g=20.0%ofphenol.
Weightpercentofglycerin=(10g100%)/12.50g=80.0%ofglycerin.
2.Aprescriptionorderreadsasfollows:
EucalyptusOil3%(v/v)inMineralOil.
Dispense30.0mL.
Whatquantitiesshouldbeusedforthisprescription?Usingthevolumepercentequationabove,thecalculationis
asfollows.
AmountofEucalyptusOil:
3%=(VolumeofoilinmL/30.0mL)100%
Solvingtheequation,thevolumeofoil=0.90mL
AmountofMineralOil:
To0.90mLofEucalyptusOiladdsufficientMineralOiltoprepare30.0mL.
3.Aprescriptionorderreadsasfollows:
Zincoxide
7.5g
Calamine
7.5g
Starch
15g
Whitepetrolatum 30g
Calculatethepercentageconcentrationforeachofthefourcomponents.Usingtheweightpercentequationabove,
thecalculationisasfollows.
Totalweight=7.5g+7.5g+15g+30g=60.0g.
Weightpercentofzincoxide=(7.5gzincoxide/60gointment)100%=12.5%.
Weightpercentofcalamine=(7.5gcalamine/60gointment)100%=12.5%.
Weightpercentofstarch=(15gstarch/60gointment)100%=25%.
Weightpercentofwhitepetrolatum=(30gwhitepetrolatum/60gointment)100%=50%.
SPECIFICGRAVITY
ThedefinitionofSpecificGravityisusuallybasedontheratioofweightofasubstanceinairat25 tothatoftheweightof
anequalvolumeofwateratthesametemperature.Theweightof1mLofwaterat25 isapproximately1g.Thefollowing
equationmaybeusedforcalculations.
SpecificGravity=(Weightofthesubstance)/(Weightofanequalvolumeofwater)
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EXAMPLES
1.Aliquidweighs125gandhasavolumeof110mL.Whatisthespecificgravity?
Theweightofanequalvolumeofwateris110g.
Usingtheaboveequation,specificgravity=125g/110g=1.14.
2.HydrochloricAcidNFisapproximately37%(w/w)solutionofhydrochloricacid(HCl)inwater.Howmanygramsof
HClarecontainedin75.0mLofHClNF?(SpecificgravityofHydrochloricAcidNFis1.18.)
CalculatetheweightofHClNFusingtheaboveequation.
Theweightofanequalvolumeofwateris75g.
SpecificGravity1.18=weightoftheHClNFg/75.0g.
Solvingtheequation,theweightofHClNFis88.5g.
NowcalculatetheweightofHClusingtheweightpercentequation.
37.0%(w/w)=(weightofsoluteg/88.5g)100.
Solvingtheequation,theweightoftheHClis32.7g.
DILUTIONANDCONCENTRATION
Aconcentratedsolutioncanbediluted.Powdersandothersolidmixturescanbetrituratedordilutedtoyieldless
concentratedforms.Becausetheamountofsoluteinthedilutedsolutionormixtureisthesameastheamountinthe
concentratedsolutionormixture,thefollowingrelationshipappliestodilutionproblems.
ThequantityofSolution1(Q1)concentrationofSolution1(C1)=thequantityofSolution2(Q2)concentrationof
Solution2(C2),or
(Q1)(C1)=(Q2)(C2).
Almostanyquantityandconcentrationtermsmaybeused.However,theunitsofthetermsmustbethesameonboth
sidesoftheequation.
EXAMPLES
1.Calculatetheamount(Q2),ing,ofdiluentthatmustbeaddedto60gofa10%(w/w)ointmenttomakea5%(w/w)
ointment.
Let(Q1)=60g,(C1)=10%,and(C2)=5%.
Usingtheaboveequation,
60g10%=(Q2)5%(w/w)
Solvingtheaboveequation,theamountofproductneeded,Q2,is120g.Theinitialamountofproductaddedwas
60g,andthereforeanadditional60gofdiluentmustbeaddedtotheinitialamounttogiveatotalof120g.
2.Howmuchdiluentshouldbeaddedto10gofatrituration(1in100)tomakeamixturethatcontains1mgofdrugin
each10goffinalmixture?
Determinethefinalconcentrationbyfirstconvertingmgtog.Onemgofdrugin10gofmixtureisthesameas
0.001gin10g.
Let(Q1)=10g,(C1)=(1in100),and(C2)=(0.001in10).
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Usingtheequationfordilution,10g(1/100)=(Q2)g(0.001/10).
Solvingtheaboveequation,(Q2)=1000g.
Because10gofthefinalmixturecontainsallofthedrugandsomediluent,(1000g10g)or990gofdiluentis
requiredtopreparethemixtureataconcentrationof0.001gofdrugin10goffinalmixture.
3.Calculatethepercentagestrengthofasolutionobtainedbydiluting400mLofa5.0%solutionto800mL.
Let(Q1)=400mL,(C1)=5%,and(Q2)=800mL.
Usingtheequationfordilution,400mL5%=800mL(C2)%.
Solvingtheaboveequation,(C2)=2.5%(w/v).
USEOFPOTENCYUNITS
SeeUnitsofPotencyintheGeneralNotices.
Becausesomesubstancesmaynotbeabletobedefinedbychemicalandphysicalmeans,itmaybenecessaryto
expressquantitiesofactivityinbiologicalunitsofpotency.
EXAMPLES
1.OnemgofPancreatincontainsnotlessthan25USPUnitsofamylaseactivity,2.0USPUnitsoflipaseactivity,
and25USPUnitsofproteaseactivity.Ifthepatienttakes0.1g(100mg)perday,whatisthedailyamylase
activityingested?
1mgofPancreatincorrespondsto25USPUnitsofamylaseactivity.
100mgofPancreatincorrespondsto100(25USPUnitsofamylaseactivity)=2500Units.
2.AdoseofpenicillinGbenzathineforstreptococcalinfectionis1.2millionunitsintramuscularly.Ifaspecific
productcontains1180unitspermg,howmanymilligramswouldbeinthedose?
1180unitsofpenicillinGbenzathinearecontainedin1mg.
1unitiscontainedin1/1180mg.
1,200,000unitsarecontainedin(1,200,0001)/1180units=1017mg.
BASEVSSALTORESTERFORMSOFDRUGS
Frequentlythebaseformofadrugisadministeredinanalteredformsuchasanesterorsaltforstabilityorotherreasons
suchastasteorsolubility.Thisalteredformofthedrugusuallyhasadifferentmolecularweight(MW),andattimesitmay
beusefultodeterminetheamountofthebaseformofthedruginthealteredform.
EXAMPLES
1.Fourhundredmilligramsoferythromycinethylsuccinate(molecularweight,862.1)isadministered.Determinethe
amountoferythromycin(molecularweight,733.9)inthisdose.
862.1goferythromycinethylsuccinatecorrespondsto733.9goferythromycin.
1goferythromycinethylsuccinatecorrespondsto(733.9/862.1)goferythromycin.
0.400gerythromycinethylsuccinatecorrespondsto(733.9/862.1)0.400gor0.3405goferythromycin.
2.Themolecularweightoftestosteronecypionateis412.6andthatoftestosteroneis288.4.Whatisthedoseof
testosteronecypionatethatwouldbeequivalentto60.0mgoftestosterone?
288.4goftestosteronecorrespondsto412.6goftestosteronecypionate.
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1goftestosteronecorrespondsto412.6/288.4goftestosteronecypionate.
60.0mgor0.0600goftestosteronecorrespondsto(412.6/288.4)0.0600=0.0858gor85.8mgoftestosterone
cypionate.
RECONSTITUTIONOFDRUGSUSINGVOLUMESOTHERTHANTHOSEONTHELABEL
Occasionallyitmaybenecessarytoreconstituteapowderinordertoprovideasuitabledrugconcentrationinthefinal
product.Thismaybeaccomplishedbyestimatingthevolumeofthepowderandliquidmediumrequired.
EXAMPLES
1.Ifthevolumeof250mgofceftriaxonesodiumis0.1mL,howmuchdiluentshouldbeaddedto500mgof
ceftriaxonesodiumpowdertomakeasuspensionhavingaconcentrationof250mgpermL?
2.Volumeof500mgofceftriaxonesodium=
3.Volumeofthediluentrequired=(2mLofsuspension) (0.2mLofCeftriaxoneSodium)=1.8mL.
4.Whatisthevolumeofdrypowdercefonicid,if2.50mLofdiluentisaddedto1gofpowdertomakeasolution
havingaconcentrationof325mgpermL?
Volumeofsolutioncontaining1gofthepowder=
Volumeofdrypowdercefonicid=3.08mLofsolution 2.50mLofdiluent=0.58mL.
ALLIGATIONALTERNATEANDALGEBRA
AlligationAlligationisarapidmethodofdeterminingtheproportionsinwhichsubstancesofdifferentstrengthsaremixed
toyieldadesiredstrengthorconcentration.Oncetheproportionisfound,thecalculationmaybeperformedtofindthe
exactamountsofsubstancesrequired.Setuptheproblemasfollows.
1.Placethedesiredpercentageorconcentrationinthecenter.
2.Placethepercentageofthesubstancewiththelowerstrengthonthelowerlefthandside.
3.Placethepercentageofthesubstancewiththehigherstrengthontheupperlefthandside.
4.Subtractthedesiredpercentagefromthelowerpercentage,andplacetheobtaineddifferenceontheupperright
handside.
5.Subtractthehigherpercentagefromthedesiredpercentage,andplacetheobtaineddifferenceonthelowerright
handside.
Theresultsobtainedwilldeterminehowmanypartsofthetwodifferentpercentagestrengthsshouldbemixedtoproduce
thedesiredpercentagestrengthofadrugmixture.
EXAMPLES
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1.Howmuchointmenthavinga12%drugconcentrationandhowmuchointmenthavinga16%drugconcentration
mustbeusedtomake1kgofapreparationcontaininga12.5%drugconcentration?
Inatotalof4.0partsof12.5%product,3.5partsof12%ointmentand0.5partsof16%ointmentareneeded.
4partscorrespondto1kgor1000g.
1partcorrespondsto250g.
3.5partscorrespondto3.5250gor875g.
0.5partscorrespondto0.5250gor125g.
2.HowmanymLof20%dextroseinwaterand50%dextroseinwaterareneededtomake750mLof35%dextrose
inwater?
Inatotalof30partsof35%dextroseinwater,15partsof50%dextroseinwaterand15partsof20%dextrosein
waterarerequired.
30partscorrespondto750mL.
15partscorrespondto375mL.
Thususe375mLofthe20%solutionand375mLofthe50%solutiontopreparetheproduct.
AlgebraInsteadofusingalligationtosolvetheaboveproblems,algebramaybeused,followingtheschemeoutlined
below.
Inordertorepresentthetotalamount(weights,parts,orvolumes)ofthefinalmixtureorsolution,1oraspecifiedamountis
used.
Letxbetheamountofoneportionand[1(orthespecifiedamount)x]betheremainingportion.Setuptheequation
accordingtothestatementbelow,andsolve.
Theamountinonepartplustheamountintheotherpartequalsthetotalamountinthefinalmixtureorsolution.
EXAMPLES
1.Howmuchointmenthavinga12%drugconcentrationandhowmuchointmenthavinga16%drugconcentration
mustbeusedtomake1kgofapreparationcontaininga12.5%drugconcentration?
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Let1kgbethetotalamountofointmenttobeprepared,letxbethequantity,inkg,ofthe12%ointment,andlet(1
x)bethequantityinkgofthe16%ointment.Theequationisasfollows:
(12/100)x+(16/100)(1x)=(12.5/100)(1).
Solvingtheequation,xequals0.875kgofthe12%ointmentand(1x)equals(10.875)or0.125kgofthe16%
ointment.
2.HowmanymLof20%dextroseinwaterand50%dextroseinwaterareneededtomake750mLof35%dextrose
inwater?
Letxbethevolume,inmL,ofthe20%solution,andlet(750x)bethevolumeinmLofthe50%solution.The
equationisasfollows:
(20/100)x+(50/100)(750x)=(35/100)(750).
Solvingtheequation,xequals375mLofthe20%solutionand(750x)equals(750375)or375mLofthe50%
solution.
MOLAR, MOLAL,ANDNORMALCONCENTRATIONS
SeeConcentrationsintheGeneralNotices.
MolarityThemolarconcentration,M,ofthesolutionisthenumberofmolesofthesolutecontainedinoneLofsolution.
MolalityThemolalconcentration,m,isthenumberofmolesofthesolutecontainedinonekilogramofsolvent.
NormalityThenormalconcentration,N,ofasolutionexpressesthenumberofmilliequivalents(mEq)ofsolutecontained
in1mLofsolutionorthenumberofequivalents(Eq,gramequivalentweight)ofsolutecontainedin1Lofsolution.When
usingnormality,thepharmacistmustapplyquantitativechemicalanalysisprinciplesusingmolecularweight(MW).
Normalitydependsonthereactioncapacityofachemicalcompoundandthereforethereactioncapacitymustbeknown.
Foracidsandbases,reactioncapacityisthenumberofaccessibleprotonsavailablefrom,orthenumberofprotonbinding
sitesavailableon,eachmolecularaggregate.Forelectrontransferreactions,reactioncapacityisthenumberofelectrons
gainedorlostpermolecularaggregate.
EXAMPLES
1.Howmuchsodiumbicarbonatepowderisneededtoprepare50.0mLofa0.07Nsolutionofsodiumbicarbonate
(NaHCO3)?(MWofNaHCO3is84.0gpermol.)
Inanacidorbasereaction,becauseNaHCO3mayactasanacidbygivinguponeproton,orasabaseby
acceptingoneproton,oneEqofNaHCO3iscontainedineachmoleofNaHCO3.Thustheequivalentweightof
NaHCO3is84g.[NOTEThevolume,inL,normalityofasolutionequalsthenumberofequivalentsinthe
solution.]
ThenumberofequivalentsofNaHCO3required=(0.07Eq/L)(50.0mL/1000mL/L)=0.0035equivalents.
1equivalentweightis84.0g.
0.0035equivalentsequals84.0g/Eq0.0035Eq=0.294g.
2.Aprescriptioncallsfor250mLofa0.1Nhydrochloricacid(HCl)solution.HowmanymLofconcentrated
hydrochloricacidareneededtomakethissolution?[NOTEThespecificgravityofconcentratedhydrochloricacid
is1.18,themolecularweightis36.46andtheconcentrationis37.5%(w/w).Becausehydrochloricacidfunctions
asanacidandreactsbygivinguponeprotoninachemicalreaction,1Eqiscontainedineachmoleofthe
compound.Thustheequivalentweightis36.46g.]
ThenumberofequivalentsofHClrequiredis0.250L0.1N=0.025equivalents.
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1equivalentis36.46g.
0.025equivalentscorrespondto0.025Eq36.46g/Eq=0.9115g.
37.5gofpureHClarecontainedin100gofconcentratedHCl.
Thus1gofpureHCliscontainedin(100/37.5)g=2.666gofconcentratedacid,and0.9115giscontainedin
(0.91152.666)gor2.43gofconcentratedacid.
Inordertodeterminethevolumeofthesuppliedacidrequired,usethedefinitionforspecificgravityasshown
below.
Specificgravity=(weightofthesubstance)/(weightofanequalvolumeofwater).
1.18=2.43g/(weightofanequalvolumeofwater).
Theweightofanequalvolumeofwateris2.056gor2.06g,whichmeasures2.06mL.Thus,2.06mLof
concentratedacidisrequired.
MILLIEQUIVALENTSANDMILLIMOLES
NOTEThissectionaddressesmilliequivalents(mEq)andmillimoles(mmol)astheyapplytoelectrolytesfordosage
calculations.
ThequantitiesofelectrolytesadministeredtopatientsareusuallyexpressedintermsofmEq.Thistermmustnotbe
confusedwithasimilartermusedinquantitativechemicalanalysisasdiscussedabove.Weightunitssuchasmgorgare
notoftenusedforelectrolytesbecausetheelectricalpropertiesofionsarebestexpressedasmEq.Anequivalentisthe
weightofasubstance(equivalentweight)thatsuppliesoneunitofcharge.Anequivalentweightistheweight,ing,ofan
atomorradicaldividedbythevalenceoftheatomorradical.Amilliequivalentisonethousandthofanequivalent(Eq).
Becausetheionizationofphosphatedependsonseveralfactors,theconcentrationisusuallyexpressedinmillimoles,
moles,ormilliosmoleswhicharedescribedbelow.[NOTEEquivalentweight(Eq.wt)=wt.ofanatomorradical(ion)in
g/valence(orcharge)oftheatomorradical.Milliequivalentweight(mEq.wt)=Eq.wt.(g)/1000.]
EXAMPLES
1.Potassium(K+)hasagramatomicweightof39.10.ThevalenceofK+is1+.Calculateitsmilliequivalentweight
(mEqwt).
Eqwt=39.10g/1=39.10g
mEqwt=39.10g/1000=0.03910g=39.10mg
2.Calcium(Ca2+)hasagramatomicweightof40.08.Calculateitsmilliequivalentweight(mEqwt).
Eqwt=40.08g/2=20.04g
mEqwt.=20.04g/1000=0.02004g=20.04mg
NOTETheequivalentweightofacompoundmaybedeterminedbydividingthemolecularweightingbythe
productofthevalenceofeitherrelevantionandthenumberoftimesthisionoccursinonemoleculeofthe
compound.
3.Howmanymilliequivalentsofpotassiumion(K+)arethereina250mgPenicillinVPotassiumTablet?[NOTE
MolecularweightofpenicillinVpotassiumis388.48gpermolthereisonepotassiumatominthemoleculeand
thevalenceofK+is1.]
Eqwt=388.48g/[1(valence)1(numberofcharges)]=388.48g.
mEqwt=388.48g/1000=0.38848g=388.48mg.
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11/10/2016
(250mgperTablet)/(388.48mgpermEq)=0.644mEqofK+perTablet.
4.Howmanyequivalentsofmagnesiumionandsulfateionarecontainedin2mLofa50%MagnesiumSulfate
Injection?(MolecularweightofMgSO47H2Ois246.48gpermol.)
Amountofmagnesiumsulfatein2mLof50%MagnesiumSulfateInjection
EqwtofMgSO4.7H2O=MW(g)/(valenceofspecifiedionnumberofspecifiedionsinonemoleofsalt).
Forthemagnesiumion:
Thenumberofequivalentsiscalculatedasfollows:
246.48/[2(valence)1(numberofionsinthecompound)]=123.24g/Eqofmagnesiumion.
Thenumberofequivalentsin1gis1g/123.24g/Eq=0.008114Eq.
ThenumberofmEqmaybecalculatedasfollows.
ThemEqwt=Eqwt(g)/1000=(123.24g/Eq)/1000=0.12324g.
Thenumberofmilliequivalentsofmagnesiumionin1gis1g/0.12324g/mEq=8.114mEq.
Forthesulfateion:
Thenumberofequivalentsiscalculatedasfollows:
246.48/[2(valence)1(numberofionsinthecompound)]=123.24g/Eqofsulfateion.
Thenumberofequivalentsin1gis1g/123.24g/Eq=0.008114Eq.
ThenumberofmEqmaybecalculatedasfollows.
ThemEqwt=Eqwt(g)/1000=(123.24g/Eq)/1000=0.12324g.
Thenumberofmilliequivalentsofsulfateionin1gis1g/0.12324g/mEq=8.114mEq.
5.AvialofSodiumChlorideInjectioncontains3mEqofsodiumchloridepermL.Whatisthepercentagestrengthof
thissolution?(Molecularweightofsodiumchlorideis58.44gpermol.)
1mEq=1Eq/1000=58.44g/1000=0.05844g=58.44mg.
Amountofsodiumchloridein3mEqpermL=58.44mgpermEq3mEqpermL=175.32mgpermL.
Usingmolsandmmols
AnumberofcountrieshaveadoptedtheInternationalSystemofUnitsandnolongercalculatedosesusingmEqas
describedabove,butinsteadusethetermsmoles(mol)andmillimoles(mmol).InUSP28NF23,theInternationalSystem
ofUnitsisusedexceptforthelabelingofelectrolytes.
Definitions
Amoleequalsonegramatomicweightorgrammolecularweightofasubstance.
Amillimoleequals1/1000ofamole.
EXAMPLES
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11/10/2016
1.Potassium(K)hasagramatomicweightof39.10.Calculateitsweightinmillimoles(mmol).
DrugorExcipient E FPDepression
Theweightofonemoleis39.10gandtheweightinmillimolesis39.10g/1000=0.0391gor39.1mg.
2.HowmanymillimolesofPenicillinVareinatabletthatcontains250mgofPenicillinVPotassium?(Molecular
weightofpenicillinVpotassiumis388.48gpermol.)
Theweightofonemoleis388.48andtheweightinmillimolesis388.48/1000=0.3848gor388.48mg.Thusthere
are250mg/388.48mg/mmol=0.644mmolofPenicillinVionpertablet.
ISOOSMOTICSOLUTIONS
Thefollowingdiscussionandcalculationshavetherapeuticimplicationsinpreparationsofdosageformsintendedfor
ophthalmic,subcutaneous,intravenous,intrathecal,andneonataluse.
Cellsofthebody,suchaserythrocytes,willneitherswellnorshrinkwhenplacedinasolutionthatisisotonicwiththebody
fluids.However,themeasurementoftonicity,aphysiologicalproperty,issomewhatdifficult.Itisfoundthata0.9%(w/v)
solutionofsodiumchloride,whichhasafreezingpointof0.52 ,isisotonicwithbodyfluidsandissaidtobeisoosmotic
withbodyfluids.Incontrasttoisotonicity,thefreezingpointdepressionisaphysicalproperty.Thusmanysolutionswhich
areisoosmoticwithbodyfluidsarenotnecessarilyisotonicwithbodyfluids,e.g.,asolutionofurea.Neverthelessmany
pharmaceuticalproductsarepreparedusingfreezingpointdataorrelatedsodiumchloridedatatopreparesolutionsthatare
isoosmoticwiththebodyfluids.Acloselyrelatedtopicisosmolarity(seeOsmolalityandOsmolarity 785 ).
Freezingpointdataorsodiumchlorideequivalentsofpharmaceuticalsandexcipients(seeTable1below)maybeusedto
prepareisoosmoticsolutions,asshownintheexamplesbelow.
Table1.SodiumChlorideEquivalents(E)andFreezingPoint(FP)Depressionsfora1%SolutionoftheDrugorExcipent
DrugorExcipient E FPDepression
Atropinesulfate 0.13
0.075
Sodiumchloride 1.00
0.576
EXAMPLE
Determinetheamountofsodiumchloriderequiredtoprepare60mLofanisoosmoticsolutionofatropinesulfate0.5%using
thesodiumchlorideequivalentvaluesandalsothefreezingpointdepressionvalues.
Usingthesodiumchlorideequivalentvalues
Thetotalamountofsubstancesequivalenttosodiumchloride(fora0.9%solution)=(0.9g/100mL)60mL=0.54g.
Theamountofatropinesulfaterequired=(0.5g/100mL)60mL=0.3g.
1gofatropinesulfateisequivalentto0.13gofsodiumchloride.
0.3gatropinesulfateisequivalentto0.30.13g=0.039gofsodiumchloride.
Thustherequiredamountofsodiumchlorideis0.540.039=0.501gor0.50g.
Usingfreezingpointdepressionvalues
Thefreezingpointdepressionrequiredis0.52 .
A1%solutionofatropinesulfatecausesafreezingpointdepressionof0.075 .
A0.5%solutionofatropinesulfatecausesafreezingpointdepressionof0.075 0.5=0.0375 .
Theadditionalfreezingpointdepressionrequiredis0.52 0.0375 =0.482 .
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A1%solutionofsodiumchloridecausesafreezingpointdepressionof0.576 .
A(1%/0.576)solutionofsodiumchloridecausesafreezingpointdepressionof1 .
A(1%/0.576)0.482=0.836%solutionofsodiumchloridecausesafreezingpointdepressionof0.482 .
Therequiredamountofsodiumchlorideis(0.836g/100mL)60mL=0.502gor0.50g.
FLOWRATESININTRAVENOUSSETS
Somecalculationsconcerningflowratesinintravenoussetsareprovidedbelow.[NOTEExamplesbelowarenottobeused
fortreatmentpurposes.]
EXAMPLES
1.SodiumHeparin8,000unitsin250mLSodiumChlorideInjection0.9%solutionaretobeinfusedover4hours.The
administrationsetdelivers20dropspermL.
WhatistheflowrateinmLperhour?
In4hours,250mLaretobedelivered.
In1hour,250mL/4=62.5mLaredelivered.
Whatistheflowrateindropsperminute?
In60minutes,62.5mLaredelivered.
In1minute,62.5mL/60=1.04mLaredelivered.
1mL=20drops.
1.04mL=1.0420drops=20.8drops.
Thusin1minute,20.8or21dropsareadministered.
2.A14.5kgpatientistoreceive50mgofSodiumNitroprussidein250mLofdextrose5%inwater(D5W)attherate
of1.3gperkgperminute.Thesetdelivers50dropspermL.
CalculatetheflowrateinmLperhour.
Thedosefor1kgis1.3gperminute.
The14.5kgpatientshouldreceive14.51.3g=18.85gperminute.
50mgor50000gofdrugarecontainedin250mLofD5W.
18.85garecontainedin250mL18.85/50000=0.09425mLD5W,whichisadministeredeveryminute.
In1minute,0.09425mLareadministered.
In1houror60minutes,600.09425mL=5.655or5.7mLareadministered.
Calculatetheflowrateindropsperminute.
1mLcorrespondsto50dropsperminute.
0.09425mLcorrespondsto0.0942550=4.712or4.7dropsperminute.
TEMPERATURE
TherelationshipbetweenCelsiusdegrees( C)andFahrenheitdegrees( F)isexpressedbythefollowingequation:
16/20
11/10/2016
9( C)=5( F)160,
inwhich Cand FarethenumbersofCelsiusdegreesandFahrenheitdegrees,respectively.
EXAMPLES
1.Convert77 FtoCelsiusdegrees.
9( C)=5( F)160
C=[5( F)160]/9=[(577)160]/9=25 C
2.Convert30 CtoFahrenheitdegrees.
9( C)=5( F)160
F=[9( C)+160]/5=[(930)+160]/5=86 F
TherelationshipbetweentheKelvinandtheCelsiusscalesisexpressedbytheequation:
K= C+273.1,
inwhichKand CarethenumbersofKelvindegreesandCelsiusdegrees,respectively.
APPLICATIONOFMEANKINETICTEMPERATURE
SeePharmaceuticalStability 1150 forthedefinitionofmeankinetictemperature(MKT).MKTisusuallyhigherthanthe

arithmeticmeantemperatureandisderivedfromtheArrheniusequation.MKTaddressestemperaturefluctuationsduring
thestorageperiodoftheproduct.Themeankinetictemperature,TK,iscalculatedbythefollowingequation:
inwhichDHistheheatofactivation,whichequals83.144kJpermol(unlessmoreaccurateinformationisavailablefrom
experimentalstudies)Ristheuniversalgasconstant,whichequals8.3144103kJperdegreepermolT1isthe
averagetemperature,indegreesKelvin,duringthefirsttimeperiod,e.g.,thefirstweekT2istheaveragetemperature,in
degreesKelvin,duringthesecondtimeperiod,e.g.,secondweekandTnistheaveragetemperature,indegreesKelvin
duringthenthtimeperiod,e.g.,nthweek,nbeingthetotalnumberoftemperaturesrecorded.Themeankinetictemperature
iscalculatedfromaveragestoragetemperaturesrecordedoveraoneyearperiod,withaminimumoftwelveequallyspaced
averagestoragetemperatureobservationsbeingrecorded(seePharmaceuticalStability 1150 .Thiscalculationcanbe
performedmanuallywithapocketcalculatororelectronicallywithcomputersoftware.
EXAMPLES
1.Themeansofthehighestandlowesttemperaturesfor52weeksare25 Ceach.CalculatetheMKT.
n=52
DH/R=10,000K
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11/10/2016
Lowest
Highest
T1,T2,...,Tn=25
C=273.1+25=298.1K
Temperature
R=0.0083144kJK
n Month
(in1mol
C) 1
Temperature(in
C)
Average
Average
Temperature Temperature
(inK)
(in C)
DH/RT
eDH/RT
DH=83.144kJpermol
ThecalculatedMKTis25.0 C.Thereforethecontrolledroomtemperaturerequirementismetbythispharmacy.
[NOTEIftheaveragesofthehighestandlowestweeklytemperaturesdifferedfromeachotherandwereinthe
allowedrangeof15 Cto30 C(seeControlledRoomTemperatureunderPreservation,Packaging,Storage,and
LabelingintheGeneralNotices),theneachaveragewouldbesubstitutedindividuallyintotheequation.The
remainingtwoexamplesillustratesuchcalculations,exceptthatthemonthlyaveragesareused]
2.ApharmacyrecordedayearlyMKTonamonthlybasis,startinginJanuaryandendinginDecember.Eachmonth,
thepharmacyrecordedthemonthlyhighesttemperatureandthemonthlylowesttemperature,andtheaverageof
thetwowascalculatedandrecordedfortheMKTcalculationattheendoftheyear.
Table2.DataforCalculationofMKT
Lowest
Temperature
n Month
(in C)
1
Jan.
Highest
Temperature(in
C)
15
27
Average
Average
(inK)
(in C)
DH/RT
21
294.1
eDH/RT
34.002 1.71010
15
Feb.
20
25
22.5
295.6
33.830 2.03310
15
Mar.
17
25
21
294.1
34.002 1.71010
15
Apr.
20
25
22.5
295.6
33.830 2.03310
15
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n Month
5 May
Lowest
Temperature
Highest
Temperature(in
(in C)
22
C)
27
Average
Average
(inK)
(in C)
DH/RT
eDH/RT
24.5
297.6
33.602 2.55110
15
6 June
15
25
20
293.1
34.118 1.52310
15
July
20
26
23
296.1
33.772 2.15210
15
Aug.
22
26
24
297.1
33.659 2.4111015
9 Sept.
23
27
25
298.1
33.546 2.69910
15
10 Oct.
20
28
24
297.1
33.659 2.4111015
11 Nov.
20
24
22
295.1
33.887 1.91910
15
12 Dec.
22
28
25
298.1
33.546 2.69910
15
FromthesedatatheMKTmaybeestimatedoritmaybecalculated.Ifmorethanhalfoftheobserved
temperaturesarelowerthan25 Candameanlowerthan23 Cisobtained,theMKTmaybeestimatedwithout
performingtheactualcalculation.
a.ToestimatetheMKT,therecordedtemperaturesareevaluatedandtheaverageiscalculated.Inthiscase,
thecalculatedarithmeticmeanis22.9 C.Therefore,theaboverequirementsaremetanditcanbe
concludedthatthemeankinetictemperatureislowerthan25 C.Therefore,thecontrolledroom
temperaturerequirementismet.
b.Thesecondapproachistoperformtheactualcalculation.
n=12
ThecalculatedMKTis23.0 C,sothecontrolledroomtemperaturerequirementismet.[NOTEThesedataand
calculationsareusedonlyasanexample.]
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11/10/2016
3.Anarticlewasstoredforoneyearinapharmacywheretheobservedmonthlyaverageofthehighestandlowest
temperatureswas25 C(298.1K),exceptforonemonthwithanaverageof28 C(301.1K).CalculatetheMKTof
thepharmacy.
n=12
ThecontrolledroomtemperaturerequirementisnotmetbecausethecalculatedMKTexceeds25 C.(SeeNotein
Example2above.)
AuxiliaryInformationStaffLiaison:ClaudiaC.Okeke,Ph.D.,AssociateDirector
ExpertCommittee:(CRX05)CompoundingPharmacy05
USP29NF24Page3006
PharmacopeialForum:VolumeNo.31(3)Page847
PhoneNumber:13018168243
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TherelationshipbetweenCelsiusdegrees( C)andFahrenheitdegrees( F)isexpressedbythefollowingequation:

SeePharmaceuticalStability 1150 forthedefinitionofmeankinetictemperature(MKT).MKTisusuallyhigherthanthe

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